Warning letter
Musculoskeletal Transplant Foundation: warning letter of Apr 11, 2013
FDA warning letter 391215 · New Jersey District Office
Key facts
| Reference number | 391215 |
|---|---|
| Company | Musculoskeletal Transplant Foundation |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Apr 11, 2013 |
| Posted date | Apr 11, 2013 |
| Issuing office | New Jersey District Office |
| Product type | Biologics |
| CFR sections cited | 1271.200(b), 1271, 1271.160(b)(5), 1271.180(a), 1271.265(c)(2) |
| Inspection city | Edison |
| Inspection ZIP | 08837 |
| Inspection start date | Sep 17, 2012 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: